Failure mode and effects analysis: a comparison of two common risk prioritisation methods

Area of Science:

• Healthcare Risk Management
• Patient Safety Analysis
• Quality Improvement Methodologies

Background:

• Failure Mode and Effects Analysis (FMEA) is a risk assessment tool increasingly adopted in healthcare.
• Traditional FMEA methods can be resource-intensive, requiring significant time and training.
• A need exists for efficient FMEA approaches in clinical settings.

Purpose of the Study:

• To compare a simplified FMEA scoring method with the traditional Risk Priority Number (RPN) method.
• To assess the congruence between simplified and traditional FMEA in identifying critical failures.
• To evaluate the utility of a simplified FMEA for healthcare organizations.

Main Methods:

• An FMEA was performed on the operating room (OR) to intensive care unit (ICU) handoff process.
• Failures were scored using traditional RPN and a simplified 'high', 'medium', 'low' risk method.
• Congruence was measured by comparing failures identified as critical (RPN≥300) by the traditional method with those designated 'high risk' by the simplified method.

Main Results:

• 79 process failures were identified in the OR-to-ICU handoff.
• The simplified method identified 22 of 24 high-risk failures (RPN≥300) from the traditional method, achieving 92% agreement.
• The simplified method showed 50% agreement with the top 20% of Criticality Indices (CI≥60).

Conclusions:

• A simplified FMEA scoring method is a practical tool for healthcare organizations with limited FMEA expertise.
• The simplified method demonstrates high congruence in identifying critical failures.
• While effective for identifying high-risk failures, the simplified method offers less discrimination in ranking compared to the traditional FMEA.